For the Consumer

Along with its needed effects, cefpodoxime (the active ingredient contained in Vantin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cefpodoxime:

Some side effects of cefpodoxime may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Gastrointestinal

Diarrhea and loose stools may be dose-related and has been reported in 10.4% of patients taking 800 mg cefpodoxime (the active ingredient contained in Vantin) per day, compared to 5.7% of patients taking 200 mg per day. Ten percent of these patients tested positive Clostridium difficile organisms or toxins.

C difficile was isolated in six of six volunteers given cefpodoxime for 10 days compared with one of six volunteers given placebo. The symptoms associated with C difficile were mild and did not result in withdrawal from the study. The excretion of C difficile in the stool was not statistically associated with the passage of loose stools and none of the subjects went on to develop pseudomembranous colitis.

Hepatic

Hepatic side effects have included increased AST, ALT, GGT, alkaline phosphatase, bilirubin, and LDH. These changes have generally been transient and clinically insignificant. Acute liver injury has been reported during postmarketing experience. Cephalosporins as a class have been associated with hepatic dysfunction including cholestasis.[Ref]

Respiratory

Respiratory side effects have included asthma, cough, epistaxis, rhinitis, wheezing, bronchitis, dyspnea, pleural effusion, pneumonia, and sinusitis in less than 1% of patients. Pulmonary infiltrate with eosinophilia has been reported during postmarketing experience.[Ref]

Renal

Renal side effects have included increased BUN and creatinine. These changes have generally been transient and clinically insignificant. Purpuric nephritis has been reported during postmarketing experience. Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.[Ref]

Nervous system

Nervous system side effects have included headache (1%). Dizziness, insomnia, somnolence, anxiety, shakiness, nervousness, cerebral infarction, change in dreams, impaired concentration, confusion, nightmares, paresthesia, vertigo, tinnitus, hallucination, hyperkinesia, syncope, and somnolence have been reported in less than 1% of patients. Some cephalosporins have been associated with seizures in renally impaired patients.[Ref]

Genitourinary

Genitourinary side effects have included vaginal fungal infections (1%) and vulvovaginal infections (1.3%). Hematuria, urinary tract infections, metrorrhagia, dysuria, urinary frequency, nocturia, penile infection, proteinuria, vaginitis, and vaginal pain have been reported in less than 1% of patients. Change in quantity of urine has been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects have included myalgia (less than 1%).[Ref]

Cardiovascular

Metabolic

Metabolic side effects have included dehydration, gout, peripheral edema, and weight increase in less than 1% of patients. Hyperglycemia, hypoglycemia, hypoalbuminemia, hypoproteinemia, hyperkalemia, and hyponatremia have been reported. These changes have generally been transient and clinically insignificant.[Ref]

Ocular

Ocular side effects have included eye irritation in less than 1% of patients.[Ref]